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FDA 510(k)

Pristina Serena 3D

K-Number: K182951 · 2019-01-18

ApplicantGE Healthcare
Decision Date2019-01-18
Product CodeMUE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Pristina Serena 3D is the device name listed in this FDA 510(k) record. The listed applicant is GE Healthcare. It received FDA 510(k) clearance on 2019-01-18 under 510(k) number K182951. The device is classified under product code MUE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Pristina Serena 3D?

Pristina Serena 3D is a medical device that received FDA 510(k) clearance on 2019-01-18. The listed applicant is GE Healthcare. The 510(k) number is K182951.

When did Pristina Serena 3D receive FDA 510(k) clearance?

Pristina Serena 3D received FDA 510(k) clearance on 2019-01-18, under 510(k) number K182951.

Who is the listed applicant for Pristina Serena 3D?

The FDA 510(k) record lists GE Healthcare as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pristina Serena 3D?

The FDA product code for Pristina Serena 3D is MUE.

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Other records listing GE Healthcare as applicant

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Related Devices (Code: MUE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253678MAMMOMAT B.brilliant (11372950)Siemens Medical Solutions USA, Inc.K254092Bellalun 2D (VDMS-1000S)Vieworks Co., Ltd.K260087Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena BrightGE Medical Systems SCSK243420HESTIAGenoray Co., Ltd.K2438492430TCA with Xmaru WRayence Co., Ltd.K241113VIVIX-MVieworks Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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